Operator II, Production

ZipRecruiter; Stevenage; On-site; GBP 30,000 - 40,000; Full time

Job summary

Join a leading biotech company as an Operator II in GMP manufacturing. This shift-based role involves ensuring high-quality production of cell-based therapies while adhering to strict GMP regulations. You will be responsible for executing production processes, maintaining cleanroom environments, and supporting operational improvements. If you have a passion for GMP manufacturing and want to make a difference, we’d love to hear from you!

Qualifications

• Minimum 2 years of GMP manufacturing cleanroom experience.
• Experience in shift-based, high-performance environments.

Responsibilities

• Execute production processes and operate equipment per GMP requirements.
• Conduct raw material transfers and maintain cleanroom environments.
• Perform cell culture activities and support batch review execution.

Skills

Attention to Detail

Communication

Teamwork

Organizational Skills

Tools

Microsoft Office

Lean Six Sigma

Job description

Job Description

This job is with Autolus Therapeutics, an inclusive employer and a member of myGwork – the largest global platform for the + business community. Please do not contact the recruiter directly.

Autolus is seeking a highly motivated Operator II to join our GMP manufacturing team. This shift-based role involves weekend working and operates across 6 AM – 10 PM. You will play a key role in ensuring the production of high-quality cell-based products while maintaining compliance with GMP regulations, safety standards, and company procedures.

Key Responsibilities

As an Operator II, you will:

• Execute production processes and operate associated equipment in line with GMP and GDP requirements.
• Maintain cleanroom environments through sterile room maintenance, hydrogen peroxide vapour gassing, and environmental monitoring (EM).
• Conduct raw material transfers, particulate cleaning and disinfection, material receipt, and drug product shipment.
• Accurately complete documentation and data entry, ensuring compliance with regulatory standards.
• Perform cell culture activities including sampling, counting, washing, activation, feeding, harvesting, and magnetic enrichment/depletion (MACS).
• Carry out aseptic manipulations in Grade A environments and meet associated BROTH qualification (OAQ) standards.
• Support batch review execution and collaborate with cross-functional teams to ensure smooth workflow.
• Lead or support operational deviations, process risk assessments, and continuous improvement (CI) initiatives.
• Assist in the authoring and revision of SOPs, SWIs, and risk assessments to maintain process efficiency and compliance.
• Provide guidance and mentoring to junior team members, supporting their training and development.

Skills & Experience

• Minimum 2 years of GMP manufacturing cleanroom experience (essential).
• Experience working in shift-based, high-performance environments ().
• Strong understanding of GxP, ATMP production, QMS, and environmental health & safety requirements.
• Ability to follow detailed instructions, work with attention to detail, and make quality-critical decisions.
• Proficiency in Microsoft Office (Word, Excel, Teams, PowerPoint) and familiarity with problem-solving methodologies like Lean Six Sigma ().
• Excellent communication, teamwork, and organizational skills.

Working Pattern

• This is a shift-based role requiring weekend work.
• Shifts will fall within the operational hours of 6 AM – 10 PM.

This role offers an exciting opportunity to be part of an innovative biotech company, contributing to the manufacture of next-generation cell-based therapies. If you're passionate about GMP manufacturing and eager to make a difference, we’d love to hear from you!

#LI-DNI